Specialist-IT (Laboratory Systems & Compliance)

Role PurposeThe incumbent will be responsible for managing and supporting IT operations for laboratory instruments and standalone systems used in QC and R&D laboratories, ensuring regulatory compliance, system availability, data integrity, and audit readiness in a pharmaceutical manufacturing environment.

Primary ResponsibilitiesManage day-to-day IT operations for laboratory instruments and standalone systems in QC & R&D laboratories, including but not limited to Empower, OpenLab, IC-DAS, FTIR, UV, LCMS, Auto-titrator, GC, and GC-HS.Ensure effective backup management, disaster recovery planning, and IT security controls for laboratory and standalone systems.Support and manage regulatory audits, including preparation, review, and maintenance of required IT and system-related documentation.Provide hands-on administration and support of VMware virtualization platforms.Ensure compliance with GxP guidelines, 21 CFR Part 11, Data Integrity principles, and other applicable pharmaceutical regulatory requirements.Troubleshoot complex system issues with strong problem-solving skills and coordinate effectively with OEM vendors, service providers, and internal stakeholders.Administer Active Directory and Domain Controller activities, including user management, group policies, access controls, and security restrictions.

Additional ResponsibilitiesPrepare, review, and maintain SOPs, IT policies, and system documentation in line with regulatory and company standards.Manage and document Change Control, Deviations, CAPA, and Risk Assessments related to IT and laboratory systems.Support periodic reviews, system validations, and compliance activities as per quality and regulatory requirements.Ensure continuous improvement in IT processes and system reliability within laboratory environments.

Qualifications & ExperienceBachelor's degree in Information Technology, Computer Science, or related discipline.3-6 years of relevant experience in pharmaceutical / regulated industry IT, with hands-on exposure to laboratory systems.Strong understanding of pharma compliance, audits, and validation concepts.Experience working with cross-functional teams in QC, R&D, QA, and Engineering is preferred.

Key CompetenciesStrong analytical and problem-solving skillsRegulatory and compliance mindsetEffective communication and coordination skillsAbility to work independently in a regulated environment